Sanofi rejects Philippine plea for refund on used vaccines

Department of Health Undersecretary Dr. Rolando Enrique Domingo, right, gestures besides Philippine General Hospital Director Dr. Gerardo Legaspi, during a press conference at the Department of Health office in Manila, Philippines on Friday, Feb. 2, 2018. Philippine health officials say an investigation has shown that at least 3 of 14 reported deaths of children injected with the anti-dengue vaccine supplied by French-based Sanofi Pasteur may have "causal association" to the inoculation, including two possible cases of "vaccine failure." (AP Photo/Aaron Favila)

Dr. Juliet Sio-Aguilar, right, of the Philippine General Hospital, explains her presentation during a press conference at the Department of Health office in Manila, Philippines on Friday, Feb. 2, 2018. Philippine health officials say an investigation has shown that at least 3 of 14 reported deaths of children injected with the anti-dengue vaccine supplied by French-based Sanofi Pasteur may have "causal association" to the inoculation, including two possible cases of "vaccine failure." (AP Photo/Aaron Favila)

MANILA, Philippines — A Sanofi Pasteur official said Monday that the French drugmaker couldn't comply with the Philippines' request for a refund of dengue vaccines injected on hundreds of thousands of children because it would imply that the drug is ineffective.

Thomas Triomphe, Sanofi Pasteur's Asia-Pacific chief, told a House of Representatives hearing that it's clear in "absolute terms" that the Philippines would reduce dengue infections more by using the company's Dengvaxia vaccine than by halting its use.

"Dengvaxia is an effective product," Triomphe told lawmakers. "Reimbursing doses that have been already injected, where the benefits of protection have been provided, will, de facto, imply that the vaccine is ineffective, which is not the case."

Health Secretary Francisco Duque III has said that Sanofi Pasteur has agreed to take back huge stocks of unused Dengvaxia and pay back more than a billion pesos ($20 million) to the Philippine government.

The government, however, has also asked Sanofi Pasteur to refund payment of nearly 2 billion pesos ($40 million) for Dengvaxia already used in its massive anti-dengue immunization program, which was halted last year, health officials said.

The Philippine government halted its massive immunization drive last year after Sanofi said a study showed the vaccine may increase the risks of severe dengue infection. More than 830,000 children were injected with the Dengvaxia vaccine under the campaign, which was launched in 2016 under then-President Benigno Aquino III. The campaign continued under his successor, Rodrigo Duterte, until it was stopped last year.

On Friday, Philippine health officials said the deaths of three of 14 children injected with a Sanofi Pasteur dengue vaccine may have "causal association" to the inoculation, including two who may have died because the vaccine failed. They said, however, that they need to carry out further studies to confirm their findings.

Investigators found no evidence that the rest of the 14 deaths were related to the vaccine. Officials said the deaths of at least 15 other children injected with Dengvaxia would be investigated.

Triomphe welcomed the government examination on the 14 children, which he said did not turn up any clear evidence linking their deaths to Dengvaxia.

Philippine health officials have said that publicity of concerns raised over Dengvaxia has caused the number of children receiving preventive vaccinations for other diseases to drop.

About 200,000 dengue infections are recorded by the health department each year, officials said. Dengue is a mosquito-borne viral infection found in tropical countries worldwide. It is a flu-like disease that can cause joint pain, nausea, vomiting and a rash, and can cause breathing problems, hemorrhaging and organ failure in severe cases.